The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Non-mydriatic Retinal Camera, Model Cr6-45nm.
Device ID | K980246 |
510k Number | K980246 |
Device Name: | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM |
Classification | Camera, Ophthalmic, Ac-powered |
Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Contact | Glenn Impal |
Correspondent | Glenn Impal CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Product Code | HKI |
CFR Regulation Number | 886.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-23 |
Decision Date | 1998-05-06 |
Summary: | summary |